Ceritinib (Zykadia, Novartis) has a marketing authorisation in the UK for treating adult patients with anaplastic lymphoma kinase (ALK) positive advanced non‑small‑cell lung cancer (NSCLC) previously treated with crizotinib. Ceritinib is an ALK inhibitor.
The summary of product characteristics lists the following grade 3 and 4 adverse reactions that occur in at least 5% of people having ceritinib: liver laboratory test abnormalities, fatigue, diarrhoea, nausea and hyperglycaemia. For full details of adverse reactions and contraindications, see the summary of product characteristics.
Ceritinib is taken orally, once daily. The recommended dose is 750 mg (5 × 150‑mg capsules). The company submission stated that the NHS list price is £4,923.45 for a 30‑day supply. The summary of product characteristics states that treatment should be continued as long as clinical benefit is seen. The company has agreed a patient access scheme with the Department of Health. This scheme provides a simple discount to the list price of ceritinib at the point of purchase or invoice. The level of the discount is commercial in confidence. The Department of Health considered that this patient access scheme would not constitute an excessive administrative burden on the NHS.